Changes in clinical technology allow development teams to add safety checks and balances throughout the trial process. Product developers who work closely with clinical research organizations (CROs) often set up their own oversight processes and best practices. However, the use of clinical oversight solutions is growing in popularity. This is the implementation of tools to catch issues and outliers before the data can be cleaned and reviewed. Catching issues early on can help teams save time and money while driving better results.
There are multiple clinical oversight solutions on the market but some are better than others. Make sure you get the most out of yours to drive your trials forward.
Before the implementation of key oversight tools, researchers developed their own oversight best practices and strategies. This meant it was harder to create unified practices because the protocols of one company differed from another.
“Oversight practices differ according to the investigational site model, team dynamics, and the delegation required to manage the study at that site,” says Elizabeth Weeks-Rowe, principal clinical research associate at contract research organization PPD. “Appropriate oversight is driven by active—not passive—investigator involvement, frequent communication with trusted delegates, engagement with study patients, and real-time appraisal of study/team status.”
As the need for clear oversight takes a greater role in the clinical research process, administrative bodies and researchers are working together to develop clear standards.
In 2019, Volker Hack and Brian Barnes, executive director of global clinical development, performance and systems optimization at PPD and director of clinical management at PPD respectively, discussed the regulatory guidelines ICH E6 R2 (risk management) and what they mean for CROs. These guidelines encourage researchers to start early in the risk mitigation process and communicate their needs clearly.
“The identification of critical data and processes, as well as any risks to subject safety and data integrity, should start as early as possible — usually when a draft stable protocol synopsis is available — by conducting a thorough and effective risk assessment that enables the clinical trial team to de-risk the protocol,” Hack and Barnes write.
Risk management is a key part of the clinical trial process, even from the earliest pre-trial stages. Developers need a clinical oversight tool that can be used throughout.
Even with a clinical oversight tool, researchers should have clear plans for what they will evaluate and when. These plans can help teams communicate with the CROs they work with and hold each organization to the same standards.
“The sponsor should define and assess proactively what are critical data and processes associated with the protocol,” writes Thuy Larsen, senior consultant at Pharma GCP. “Based on this, a risk management plan should be developed to support the monitoring strategy. The risk management plan should include trial-specific risks, grading of each risk and mitigation of risks.”
To start, consider which checks and balances need to be implemented internally and which can be completed by your CROs. The internal checks your team needs will determine the types of clinical oversight solutions your organization invests in.
“One way to think about which specific functions should be internally staffed for oversight of the CRO is to consider whether those functions have implications outside of the individual trial being managed by the CRO,” says Blake Jensen, VP of clinical development quality assurance and compliance at Adagio Therapeutics.
Jensen uses the example of the clinical database from one trial not having a major impact across an organization. However, if that data is used elsewhere and alongside other trials, then a company may need to invest in oversight to ensure its quality.
Trial oversight is particularly important as teams pull more sources of data each time — and compare that data to other studies and resources.
“They must identify not only the primary types of clinical data (e.g., historical and physical records, laboratory results, operative reports, etc.) but what other data are necessary,” says Marti Arvin, executive advisor at CynergisTek Cybersecurity Consultants. “Will the project be collating information from multiple sources? If so, what unique identifier(s) is needed to identify the subject’s data across those multiple sources?”
Every dataset needs to be held to the same standard and go through the same cleaning protocols.
The use of clinical oversight solutions is increasingly valuable as more administrators and industry leaders grow concerned with patient data. Good oversight will protect the security of the data you collect and share, maintaining its integrity and protecting patient information.
“One of the benefits providers and payers gain through automation, beyond reducing waste and burden, is [they] share only the necessary data needed to meet medical necessity between two trusted parties and their intermediaries,” says Jocelyn Keegan, payer practice lead at healthcare management consulting firm Point-of-Care. “Secure API interchange drives to more real-time answers, with less data in flight, leveraging modern security protocols resulting in more secure data infrastructure and increased ability to track and audit.”
Interestingly, researchers have found that patients aren’t concerned about the handling of their data. Michelle Mello, a professor of law and professor of medicine at Stanford University, along with researchers Van Lieou and Dr. Steven Goodman conducted a survey of 771 clinical trial participants about the security of their data. Less than eight percent said the potential negative consequences of data-sharing outweighed the benefits.
Instead, their primary concerns were that data sharing would make others less likely to participate in clinical trials (37 percent were very or somewhat concerned) or their data would be used for marketing purposes (34 percent).
However, patient trust is not guaranteed. If clinical trial participants think their data may be mishandled, your company and the CROs you work with could face serious reputation management challenges.
Oversight isn’t a tool to hold over your CROs. Instead, it is a relationship-building opportunity to ensure each company you work with understands your expectations and takes steps to meet them.
“The sponsor treads a thin line distinguishing between micromanaging each and every step and effective oversight in the implementation of the clinical trial,” says medical writer and researcher Poonam Balani. “Vendor oversight is a trending topic as both the vendors and the sponsors come to terms with what is expected of each of them and the associated liabilities and responsibilities while partnering together.”
A key example of this relationship-building is training, something trial developers can provide to CROs. Policy executive Chantal Worzala, principal of Alazaro Consulting, worked with the American Health Information Management Association (AHIMA) to develop principles for integrating and sharing data. One of the key principles is a focus on training and onboarding. CROs can’t be expected to immediately understand and use new data management and clinical oversight tools. Additionally, your CROs may require more collaboration than before the new tech was introduced.
“Successful automation also will require greater collaboration across the range of professionals engaged in creating, curating, sharing, and using both clinical and administrative data,” Worzala writes.
Strong relationship-building with your CROs can also ease transitions in times of change. The pandemic is a perfect example of this.
“As the COVID-19 pandemic started to affect clinical trials, it became evident that different metrics were required for trial oversight,” says Kristin Stallcup, senior director of customer success at CRO service company Covance. “While study milestone metrics are typically an extremely important measure of study conduct, many studies were paused or slowed down during the pandemic and it was unclear when they would start up again.”
This meant it was less critical to track study timelines and there was a noticeable shift to analyze patient access and participation.
Like most forms of technology, clinical oversight tools are only as effective as the people using them. With the right checks and balances in place, these tools can protect patient privacy and reduce mistakes in key datasets.